Not recruiting

Study on Letermovir for Preventing Cytomegalovirus in Heart Transplant Patients

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the prevention of Cytomegalovirus (CMV) infection in individuals who have received a heart transplant. The treatment being investigated is a medication called Letermovir, which is available in the form of film-coated tablets. Letermovir is also known by its code name, MK-8228. The purpose of the study is to explore how effective Letermovir is in preventing CMV infections in heart transplant recipients.

Participants in the study will take Letermovir tablets orally. The study will monitor the occurrence of early CMV infections or disease during the period when participants are taking the medication. Additionally, the study will observe the rates of certain blood conditions, such as leukopenia (a decrease in white blood cells) and neutropenia (a decrease in a type of white blood cell called neutrophils), during the treatment period. The study will also look at the occurrence of late CMV infections after stopping the medication and the body's immune response over time.

The study will continue for a set period, and participants will be closely monitored throughout. The goal is to gather information on the effectiveness of Letermovir in preventing CMV infections and to understand any potential side effects or resistance to the treatment. This research aims to improve the care and outcomes for heart transplant recipients who are at risk of CMV infections.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after heart transplantation. Eligibility includes being a heart transplant recipient, having a specific risk level for CMV infection, being 18 years or older, and not participating in other clinical trials.
Step 2
Medication administration
Receive PREVYMIS (letermovir) 240 mg film-coated tablets. The medication is taken orally.
The purpose is to prevent CMV infection, a common virus that can cause serious illness in heart transplant recipients.
Step 3
Monitoring and follow-up
Regular monitoring for early CMV infections or disease during the period of taking the medication.
Observation for any side effects such as leukopenia (low white blood cell count) or neutropenia (low neutrophil count).
Assessment of the body's immune response over time while on the medication.
Step 4
Post-medication observation
After stopping the medication, monitoring continues for up to 6 months to check for late CMV infections or disease.
Evaluation of any resistance to the medication that may have developed.

Who can join the trial?

5 criteria

Must be a new **heart transplant recipient**.
Must have a **moderate or high risk CMV serostatus**. This means the patient has certain levels of antibodies related to CMV, a virus that can affect people with weakened immune systems.
Must have signed an **informed consent**. This is a document that explains the study and confirms the patient agrees to participate.
Must be **18 years or older**.
Must not be enrolled in other clinical trials that might interfere with this one.

Who cannot join the trial?

4 criteria

Patients who have not received a heart transplant cannot participate.
Patients who do not have a **CMV infection** cannot participate. **CMV infection** refers to an infection caused by the cytomegalovirus, which can be serious in people with weakened immune systems, like those who have had a heart transplant.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

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Verified sites

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Verified
University Medical Center Ljubljana
Ljubljana, Slovenia

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Investigated drugs

Letermovir is a medication used in this study to prevent cytomegalovirus (CMV) infection in patients who have received a heart transplant. It works by inhibiting the replication of the virus, helping to protect the patient from developing CMV disease, which can be a serious complication after transplantation.

Letermovir

What is already known about the treatment

Letermovir – Letermovir is administered orally or intravenously and is used to prevent cytomegalovirus (CMV) infection in heart transplant recipients. It is currently recognized in medical literature as an effective prophylactic treatment for CMV, particularly in patients who have undergone organ transplants. The main therapeutic indication for letermovir is the prevention of CMV infection, which can be a significant complication in immunocompromised individuals. At the molecular level, letermovir works by inhibiting the CMV DNA terminase complex, which is essential for viral replication. It is classified pharmacologically as an antiviral medication.

Investigated diseases

CMV Infection in Heart Transplant Recipients – Cytomegalovirus (CMV) infection is a common viral infection that can occur in individuals who have received a heart transplant. This infection is caused by the CMV virus, which is a type of herpesvirus. In heart transplant recipients, the immune system is often suppressed to prevent organ rejection, making them more susceptible to infections like CMV. The virus can remain dormant in the body and reactivate, leading to symptoms such as fever, fatigue, and inflammation of the transplanted heart. Over time, CMV infection can affect the function of the transplanted organ and may lead to complications if not managed properly. The progression of the disease can vary, with some individuals experiencing mild symptoms while others may have more severe manifestations.